(62 days)
The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.
The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
This document is a 510(k) summary for a medical device (MiniLoad Syringe) and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide the detailed types of information requested in your prompt regarding AI model performance, training sets, ground truth establishment, or expert adjudication.
The document discusses acceptance criteria and device performance in the context of bench testing for a standard medical device (a syringe), not an AI-powered diagnostic or assistive technology.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document details:
- Acceptance Criteria and Device Performance (Bench Testing for a Syringe): The table on pages 4-5 compares the subject device to a predicate device regarding physical characteristics, materials, and some performance specifications. Page 6 lists general performance data categories and Biocompatibility standards used to support substantial equivalence.
- Sample Size, Data Provenance, Expert Information, Adjudication Method, MRMC Studies, Standalone Performance, Ground Truth Type, Training Set Sample Size/Ground Truth: None of this information is provided because the submission is for a physical medical device (syringe), not an AI/ML system. The "performance data" refers to standard mechanical and material tests for the syringe, not diagnostic accuracy based on human image interpretation.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).